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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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frialit-2 mh-2 abutment FRIADENT GMBH k994174 04/20/2000
mityview 4-way lateral expander speculum PRISM ENTERPRISES, INC. k000444 04/21/2000
vision r/f tilting table VILLA SISTEMI MEDICALI S.P.A. k000412 04/24/2000
response 2000 cemented hip stem DEPUY ORTHOPAEDICS, INC. k000432 04/24/2000
remote fetal medicine ultrasound system R4 TELEMEDICINE, INC. k000443 04/24/2000
accucore single action core biopsy device INRAD k000612 04/24/2000
light bond (quick cure) RELIANCE ORTHODONTIC PRODUCTS, INC. k001048 04/27/2000
medtronic aortocoronary shunt and separately packaged arteriotomy cannulae MEDTRONIC CARDIAC SURGICAL PRODUCTS k994171 04/27/2000
dixi 2 PLANMECA OY k000428 04/28/2000
guthrie latex surgical glove (pre-powdered) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD k001047 04/28/2000

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